First Episode Psychosis (FEP)
Conditions
Brief summary
The objective of the current study is to assess the impact of a five-week digital heart rate variability biofeedback (HRV-B) intervention or music listening on the well-being of first episode psychosis patients. Heart rate variability (HRV) is a measure of how an individual's heart rate can adapt to a changing environment and mental and physiological challenges. It has been well established that HRV can be regulated through actions such as slow breathing and meditation. HRV Biofeedback (HRV-B) involves breathing at a specific frequency, usually around 6 breaths per minute, which has been shown to maximize HRV. Research has shown that HRV-B interventions improved mental health symptoms in various populations including individuals at clinical high risk for psychosis.
Interventions
BEHAVIORALHeart Rate Variability Biofeedback
The HRV-B intervention will consist of five weeks of daily HRV-B practice, based on previous empirical studies that used 5 weeks (Tatschl et al, 2020) with 6 weekly lab visits or checkins. Participants will practice for 10 minutes in the morning and evening for a total of 20 minutes per day, using a wearable device and mobile app.
BEHAVIORALMusic Listening
The control group will undergo a 5 week active control intervention consisting of daily music listening and 6 weekly check ins. Control participants will listen to music through an app for 10 minutes in the morning and 10 minutes in the evening, for a total of 20 minutes daily, using a mobile app. They will be instructed to avoid doing other tasks when listening to the music to ensure consistency between individuals.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Patients with first-episode-psychosis who have been in treatment for less than 5 years * Inclusive of affective and non-affective psychosis * Aged 18-55 * A diagnosis of schizophrenia-spectrum disorders or affective psychosis including schizoaffective disorder, bipolar affective disorders and depression with psychosis based on DSM V diagnostic criteria * Able to provide written informed consent. * Patients should be stable but with symptoms present * Score a minimum of 7 on the Calgary Depression Scale.
Exclusion criteria
* Any organic neurological or cardiac conditions * Prescription of cardiovascular medication * Active severe suicidal ideation * Diabetes as this can affect HRV * Current substance abuse * An ECG will be performed on each participant prior to joining the study to exclude undiagnosed cardiac conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Symptoms | 5 weeks, 3 data points | The Chinese version of the Calgary Depression Scale (CDSS) will be administered to participants by a trained assessor biweekly at check-ins to assess depressive symptoms. Minimum score: 0 (no depression) maximum score 27 (severe depression). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| State Paranoia | 5 weeks, 6 data points | The Chinese version of the Paranoid Ideation Checklist (Chan et al, 2011) will be completed by participants weekly during lab visits. Minimum score: 18 (no state paranoia), maximum score 90 (severe state paranoia). |
| Psychotic Symptoms | 5 weeks, 2 data points | The Chinese version of the Positive and Negative Symptom Scale (PANSS) evaluation will be conducted by a trained assessor during intake and at the final visit to rate the severity of the patient's psychotic symptoms. Minimum score: 30 (minimal psychotic symptoms) maximum score: 210 (severe psychotic symptoms). |
| Heart Rate Variability (HRV) | 5 weeks, 70 data points | RR Intervals (time between heart beats) are automatically stored in the Elite HRV app after every training session. Additionally, SDNN and RMSSD as measured in the EliteHRV app will be extracted from each training session during the weekly checkins. |
| Ideas of Reference | 5 weeks, 2 data points. | The Chinese version of the Ideas of Reference Interview Scale (IRIS) will be administered to participants by a trained assessor on the initial and final lab visits. Minimum score: 0 (no ideas of reference), maximum score 15 (endorsement of all 15 themes). |
Countries
Hong Kong
Contacts
CONTACTSherry Kit Wa Chan, PhD
CONTACTSophia M Vann-Adibe, Bachelors of Science
Outcome results
None listed